The present invention relates to a blood test container for use in clinical examinations or testing of human and animals, and more particularly to a blood test container by which a whole procedure starting from blood collection and ending with measurement of blood components can be carried out with the use of a single container.
The blood component testing as heretofore practiced in clinical examinations and the like is accomplished according to the following procedure. First, blood is collected by using an injector or a vacuum blood-collecting tube. Next, the blood either transferred into a test tube or introduced into the blood-collecting tube is centrifuged to separate serum or plasma and solid matter. Subsequently, the serum or plasma separated is distributed into separately-prepared test containers for measurements.
An equipment for carrying out such measurements is commercially available, for example, under the product name xe2x80x9cORTHO HCV.AB QUICKPACKxe2x80x9d from Orthoclinical Diagnostics Co., Ltd. With the use of this testing equipment, HCV antigen screening test can be performed, for example, after serum or plasma is dripped on a reagent of the testing equipment such as by a dropping pipet.
However, the aforementioned conventional test method has required a tester to remove a cover from the blood-collecting tube and distribute the blood into metering cups during the blood collection and measurement. Thus, several opportunities have existed for the tester to contact the blood. This has imposed a risk for the tester to acquire infectious HIV, hepatitis and the like.
It is an object of the present invention to provide a blood test container and a blood test method which can facilitate the practice of a series of procedures starting from blood collection and ending with measurement of various blood components while reducing the chance for the tester to contact the blood.
The blood test container according to the present invention includes a bottom-closed tubular container and a blood test reagent fixedly accommodated in the tubular container.
For the blood test container according to the present invention which secures the test reagent within the bottom-closed blood test container, (1) the blood or its component (referring to serum or plasma previously separated from the blood) is introduced into the tubular container where it is allowed to contact the blood test reagent, or alternatively, (2) the blood is introduced into the tubular container and subsequently centrifuged so that the separated blood component, such as serum or plasma, is allowed to contact the blood test reagent. Therefore, a series of procedures from collection till measurement of the blood can be carried out without the occurrence for a tester to contact the blood.
The blood test reagent may be secured onto an inner face of the tubular container, either directly or indirectly with the aid of other supplemental members. Alternatively, the blood test reagent may be secured onto an outer surface of an inner tubular container, a second tubular container, a tubular member or the like, accommodated within the tubular container.
The xe2x80x9csecurement of the test reagent onto the inner face or xe2x80x9csecurement onto the outer facexe2x80x9d, as used in describing the present invention, is not limited to the configurations whereby the test reagent is literally secured onto the inner or outer face, and encompasses configurations whereby a liquid-form test reagent is located in contact with the inner or outer face and configuration whereby a powder-form test reagent is located in contact with the inner or outer face. Illustrating typical examples of such configurations of the blood test container, the liquid- or powder-form test reagent is located between the tubular container and any one of the inner tubular container, second tubular container and tubular member accommodated within the tubular container to contact therewith.
In accordance with the invention, the blood test container according to the present invention further includes a contact control structure effective to normally prevent the contact of blood introduced in the container with the test reagent and, when centrifuged, allow a blood component to successfully contact the test reagent. In the invention, the contact control structure operates such that it initially prevents the blood introduced into the tubular container from contacting the test reagent but, when centrifuged, permits the separated blood component to contact the test reagent.
In accordance with the invention, the aforementioned contact control structure includes an inner container portion extending along an inner face toward a bottom of said tubular container and perforated at its bottom to have a hole, and a solid member accommodated in the inner container portion for closing the hole and configured to fall down through the hole when centrifuged. Also, the blood test reagent is provided onto an inner face of the tubular container and/or an outer face of the inner container portion. Due to the presence of the solid member which closes the bottom hole of the inner container portion, the blood, when introduced into the tubular container, is initially retained to stay within the tubular container. As centrifuging is subsequently applied, the solid member is caused to fall down and the blood starts to build up in the bottom of the tubular container. After centrifugation, the separated serum or plasma is brought into contact with the test reagent.
In accordance with the invention, the contact control structure includes an open-ended tubular member accommodated in the tubular container and an annular member radially extending between the outer face of the tubular member and the inner face of the tubular container to contact therewith. The annular member is positioned to initially locate below the test reagent. Also, the blood test reagent is secured onto at least one of the inner face of the tubular container and the outer face of the tubular member. This construction permits the blood when introduced into the tubular member to flow through the bottom opening of the tubular member into the bottom of the tubular container. However, the annular member blocks the blood which is accordingly prevented from reaching to contact with the test reagent. When centrifuged, the blood in the tubular member is forced to move downward and then upward along the circumferential surface of the tubular member, whereby the annular member is pushed upward. Also, the blood, when centrifuged, is separated into serum or plasma and solid matter and the separated serum or plasma is brought into contact with the test reagent.
In accordance with the invention, the contact control structure includes an open-ended tubular member accommodated in the tubular container and having a bottom end brought into contact with an interior bottom face of the tubular container, and a pressing means for pressing the tubular member against the interior bottom face of the tubular container so that the blood introduced into the tubular member is prevented from leaking therefrom but, when centrifuged, a component of the blood is permitted to leak therefrom. Also, the blood test reagent is secured onto at least one of the inner face of the tubular container and the outer face of the tubular member. Since the pressing means acts to press the bottom end of the tubular member against the interior bottom face of the tubular container, the blood is initially prevented from leaking to leave the tubular member. When centrifuged, the blood is caused to leak from the tubular member while separated into serum or plasma and solid matter. As a result, the serum or plasma separated is brought into contact with the test reagent.
In accordance with the invention, the contact control structure includes an open-ended tubular member secured onto the inner face of the tubular container, and a solid member secured adjacent a bottom end of the tubular member for closing a bottom opening of the tubular member and adapted to fall through the bottom opening when centrifuged. Also, the test reagent is secured within the tubular member to locate at a position above the solid member. In an initial condition where the test reagent is placed within the tubular member and the bottom opening of the tubular member is closed by the solid member, the blood when introduced into the tubular container is prevented from contacting the test reagent. The subsequent centrifugation causes the solid member to fall down while separating the blood into serum or plasma and solid matter. The falling of the solid member permits the separated serum or plasma to move into the tubular member and contact the test reagent.
In accordance with the invention the blood test container according to the invention, the inner and outer peripheral surfaces of the annular member are brought into abutment against the outer face of the tubular member and the inner face of the tubular container, respectively, with the aid of paraffin of the formula CnH2n+2 (where n is 18-22, preferably 22-24). In an initial condition, the contact of blood with the test reagent is blocked by the intervention of the annular member. The blood, when collected and then centrifuged, is separated into serum or plasma and solid matter. The paraffin, when subsequently heated to a temperature of not below its melting point, is caused to melt. This permits the annular member to freely move vertically. As a result, the serum or-plasma is allowed to push the annular member upward and reach to contact the test reagent. That is, the application of heat after centrifugation results in bringing the serum or plasma into contact with the test reagent.
For the blood test container according to the invention, the contact control structure includes an open-ended tubular member having a smaller diameter than the tubular container and accommodated in the tubular container. The blood test reagent is secured onto at least one of the inner face of the tubular container and the outer face of the tubular member. Also, a space between the tubular container and the tubular member, inclusive of a region where the blood test reagent is secured, is sealed by a sealing member comprised of thixotropic material having a viscosity of 5,000-500,000 centipoise at 25xc2x0 C. Due to the presence of the sealing member which seals the space, the blood when introduced into the tubular member is prevented from flowing straight into the space. Following centrifugation causes the thixotropic sealing member to shift in location toward a bottom of the tubular container, thereby unsealing the space. When the blood test container is subsequently turned upside down or slanted, the separated serum or plasma is allowed to enter the space where it contacts the blood test reagent for reaction therewith.
For the blood test container according to the invention, the aforementioned contact control structure includes a flexible inner resin tube accommodated in the tubular container and having an outer peripheral surface portion brought into circumferential contact with an inner face of the tubular container. One end portion of the inner tube is dimensioned to have an outer diameter smaller than an inner diameter of the tubular container so that its outer peripheral surface is separated from the inner face of the tubular container to define a space therebetween. The blood test container further includes a communicating member disposed within the space so as to be moveable. Also, the blood test reagent is located within the space and secured onto the inner face of the tubular container or onto the outer face of the inner tube.
In accordance with the invention, the blood is introduced into the inner tube. In the case where the inner tube is opened at its bottom, the blood when introduced is brought straight into a bottom of the tubular container. In the alternative case where the inner tube is closed at its bottom, the blood is retained within the inner tube.
In either case, the blood is initially prevented from reaching to contact the test reagent, due to the presence of the circumferential contact of the inner tube peripheral portion and the tubular container inner face that keeps the blood away from the space within which the test reagent is located. When the blood test container is subsequently centrifuged, the communicating member is forced to move toward the circumferential contact region and finally release the circumferential contact of the outer peripheral surface portion of the inner tube and the inner face of the tubular container. As a result, the separated serum or plasma is allowed to enter the space where it contacts the blood test reagent for reaction therewith.
For the blood test container according to the invention, the inner tube may specifically be opened at its top and bottom ends and an outer diameter of its top end may be made smaller than an inner diameter of the tubular container. In this case, the blood when introduced into the inner tube is allowed to pass through the bottom opening of the inner tube down into a bottom of the tubular container. The inner tube has an upper peripheral surface portion terminating in its top end, which is spaced from the inner face of the tubular container to provide a space therebetween. The test reagent is secured within this space. The inner tube also has a lower peripheral surface portion terminating in its bottom end, which is brought into circumferential contact with the inner face of the tubular container. Accordingly, the blood when introduced into the inner tube is initially prevented from contacting the test reagent. When centrifuged, the communicating member is caused to move downward and act to release the circumferential contact of the lower peripheral surface portion of the inner tube and the inner face of the tubular container. As a result, the centrifugally-separated serum or plasma is brought into contact with the blood test reagent.
For the blood test container according to the invention, the inner tube may be closed at its bottom and an outer diameter of a near bottom portion of the inner tube may be made smaller than an inner diameter of the tubular container to space a lower peripheral surface portion of the inner tube from the inner face of the tubular container. The remaining portion, i.e., the upper peripheral surface portion of the inner tube is held in circumferential contact with the inner face of the tubular container. Accordingly, the blood is prevented from reaching to contact the test reagent. After collection of the blood, the blood test container is turned upside down and subsequently centrifuged. The centrifugation serves to separate serum or plasma from the blood. Concurrently, the communicating member is caused to move toward the upper portion of the tubular container, i.e., downwardly within the reversed blood test container. The communicating member while moved acts to release the circumferential contact of the upper peripheral surface portion of the inner tube with the inner face of the tubular container. The separated serum or plasma is then allowed to enter the space defined between the lower peripheral surface portion of the inner tube and the inner face of the tubular container and contact the blood test reagent.
The blood test container according to the invention further includes a bottom-closed second tubular container having a diameter smaller than that of the tubular container for its accommodation within the tubular container. The blood test reagent is secured onto at least one of the inner face of the tubular container and the outer face of the second tubular container. The test reagent in the form of a liquid or powder may be placed between the tubular container and the second tubular container, as stated earlier. After introduction of the blood into the second tubular container, a stopper may be placed on the blood test container to close its top opening, for example. When the blood test container is subsequently turned upside down or slanted, the blood is caused to leave the second tubular container and enter the space between the tubular container and the second tubular container. Within the space, the blood contacts and reacts with the blood test reagent secured onto the inner face of the tubular container and/or the outer face of the second tubular container. The reaction results can be observed visually or measured by using a measuring equipment such as a spectrophotometer.
In the blood test container according to the invention, the second tubular container is provided at its bottom with a plurality of through-holes having diameters of 0.1-10 xcexcm. Also, the blood test reagent is secured onto at least one of the inner face of the tubular container and the outer face of the second tubular container. The blood, when introduced into the second tubular container, is initially retained within the second tubular container. When needed, the blood test container is subsequently centrifuged. Then, the serum or plasma present in the blood is forced to pass through the hole and starts to build up in the bottom of the tubular container. After centrifugation, the serum or plasma can thus be brought into contact with the test reagent.
In accordance with the invention, the second tubular container is provided at its bottom with a plurality of through-holes having diameters of 10-400 xcexcm, and a porous bottom region including the plurality of through-holes is located at a position below the test reagent. Also, the blood test reagent is secured onto at least one of the inner face of the tubular container and the outer face of the second tubular container. The blood, when introduced into the second tubular container, is allowed to grudually leak through the though-holes into the tubular container. Accordingly, the blood introduced into the second tubular container is restricted from flowing rapidly into the outer tubular container. The gradual build-up of the blood in the tubular container retards the contact thereof with the test reagent. When needed, the blood test container is subsequently centrifuged. Then, the blood, while separated into serum or plasma and solid matter, is transferred from the second tubular container into the outer tubular container. As a result, the serum or plasma can be brought into contact with the test reagent.
For the blood test container according to the invention, the space between the tubular container and the second tubular container, inclusive of a region where the blood test reagent is secured, is sealed by a sealing member comprised of water-soluble material. When the blood is collected in or distributed into the blood test container, the blood is thus restricted from immediately flowing into the space between the inner face of the tubular container and the outer face of the second tubular member. When in use, the blood is introduced into the second tubular container. After optional centrifugation, the blood test container is turned upside down or slanted, so that a blood sample such as serum or plasma is brought into contact with the aforementioned water-soluble material. In a while after their contact, the water-soluble material is caused to dissolve. The blood sample is then allowed to enter the space between the tubular container and the second tubular container and contact the blood test reagent for reaction therewith.
For the blood test container according to the invention, the space between the tubular container and the second tubular container, inclusive of a region where the blood test reagent is secured, is sealed by a sealing member fabricated from material having a melting point of not below 40xc2x0 C. The blood when introduced into the blood test container is thus prevented from accidentally flowing straight into the space defined between the tubular container and the second tubular container. After the blood sample is introduced into the second tubular container, the blood test container is centrifuged when needed. The blood test container is then turned upside down or slanted. The sealing member, when subsequently heated to a temperature of above its melting point, is caused to melt. The blood sample is then allowed to enter the space where it contacts the blood test reagent and a reaction thereof is initiated.
The blood test container according to the invention includes a stopper. The stopper has a first stopper portion terminating in its bottom end and having a relatively small diameter dimensioned to be press fitted into a top opening of the second tubular container, and a second stopper portion upwardly neighboring the first stopper portion and configured to be press fitted into a top opening of the tubular container. The first stopper portion is provided on its peripheral surface with a groove extending upwardly from its bottom end to points which are located above its peripheral surface region that is to be press fitted in the second tubular portion. The second tubular container is provided on its inner face with a groove extending downwardly from its top end to points which are located below its inner face region that receives the first stopper portion.
When in use, the blood is introduced into the second tubular container, with the stopper being either held attached to or detached from the blood test container. When detached, the stopper is reattached to the blood test container after the blood introduction. In this instance, attachment of the stopper is accomplished in such a way to stagger the groove on the first stopper portion from the groove on the second tubular container. This prevents the blood from entering the aforementioned space. When in measurement, the blood test container is centrifuged, when needed. Subsequently, the stopper is rotated to a position where the groove on the first stopper portion comes into alignment with the groove provided on the inner face of the second tubular container, thereby assuring the provision of a flow path communicated with the space between the second tubular container and the tubular container. When the blood test container is then turned upside down or slanted, the blood is caused to pass through the flow path into the space where it is contacted with the blood test reagent.
For the blood test container according to the invention, a top opening of the second tubular container is sealed by a polymer or metal film having a thickness up to 100 xcexcm. When in measurement, the polymer or metal film is partially broken to provide an open region through which a tubular member is inserted for introduction of the blood into the second tubular container. The blood while distributed is thus prevented from entering the space between the second tubular container and the tubular container. Next, the blood test container is centrifuged, when needed, and then turned upside down. This allows the blood sample to enter the space between the second tubular container and the tubular container and react with the blood test reagent.
For the blood test container according to the invention, the top opening of the second tubular container is sealed by a film formed of material having a melting point of not below 40xc2x0 C. This film is partly broken to provide an open region through which a tubular member or the like is inserted for introduction of the blood sample into the second tubular container. This accordingly prevents the blood sample from flowing straight into the space between the second tubular container and the tubular container. Subsequently, the blood test container is centrifuged when needed, turned upside down or slanted, and then heated to a temperature of not below 40xc2x0 C. This results in melting the film formed of material having a melting point of not below 40xc2x0 C. The blood sample is then brought immediately into the space between the tubular container and the second tubular container, where it contacts the blood test reagent for reaction therewith.
In accordance with the invention, the blood test container as includes a serum or plasma separating medium accommodated in the second tubular container. Accordingly, the centrifugation steadily separates the serum or plasma from the blood and bring the separated serum or plasma into contact with the blood test reagent for reaction therewith.
The blood test container according to the invention includes a bottom-closed second tubular container which has a diameter smaller than that of the tubular container and is accommodated in the tubular container. The second tubular container is provided at its bottom with a downwardly-projecting trap portion for trapping erythrocyte and adjacent the trap portion with a hemocyte separating portion with a plurality of through-holes having diameters of 0.1-20 xcexcm.
When in use, a blood sample is introduced into the second tubular container. The subsequent centrifugation causes serum or plasma to pass through the through-holes to outside the trap portion. However, the hemocyte, because of its high specific gravity, is retained to stay within the trap portion. As a result, only the serum or plasma is allowed to leave the trap portion to enter the space between the second tubular container and the tubular container and contact the blood test reagent. It should be understood here that the centrifuging operation is not always required. In an exemplary case where the blood is vacuum collected by reducing the interior pressure of the blood test container, this pressure reduction creates a suction force which acts to pass the blood sample through the trap portion to thereby filter the serum or plasma.
In the blood test container according to the invention, the second tubular container is provided at its bottom with a plurality of through-holes. A layer consisting of 0.1-200 xcexcm hydrophilic fine particles is further placed to overlie the through-holes. When in use, the blood is first introduced into the second tubular container. When subsequently centrifuged, for example, the serum or plasma is induced to pass through the layer consisting of 0.1-200 xcexcm hydrophilic fine particles and through the through-holes into the space between the second tubular container and the tubular container. On the other hand, the hemocyte is retained within the second tubular container to stay over the hydrophilic fine particle layer. As a result, the serum or plasma alone can be brought into contact with the blood test reagent secured onto the inner face of the tubular container and/or the outer face of the second tubular container. The above centrifuging operation is not essential. For example, when the blood is vacuum collected by reducing the interior pressure of the blood test container, the pressure reduction creates a suction force which acts to pass the blood sample through the hydrophilic fine particle layer to thereby filter the serum or plasma.
In accordance with the invention, the second tubular container of the blood test container according to the invention comprises a tubular member opened at it both ends and a bottom member secured onto the bottom end of the tubular member and having a plurality of through-holes. That is, the plurality of through-holes can be provided in the bottom of the second tubular container of the blood test container according to the invention by perforating the closed bottom of the tubular container, or alternatively, by securing a perforated bottom member onto the open bottom of the tubular member.
In accordance with the invention, the second tubular container of the blood test container according to the invention has a hole at its bottom. This hole is closed by a water-soluble cover secured onto the bottom of the second tubular container.
For the blood test container according to the invention, when the blood is introduced into the second tubular container, it is initially prevented from contacting the blood test reagent, due to the presence of the water-soluble cover which closes the bottom hole of the second tubular container. However, the water-soluble cover has a tendency to dissolve into the water content either in the blood or in the serum or plasma separated when the blood is centrifuged. Accordingly, either with the lapse of time or after centrifugation, the water-soluble cover material is caused to dissolve, whereby the blood, serum or plasma is permitted to flow into the space between the second tubular container and the outer tubular container and contact the blood test reagent for reaction therewith.
In accordance with the invention, the second tubular container of the blood test container according to the invention also has a hole at its bottom. A metal or magnet cover is placed within the second tubular container in such a fashion as to close the aforementioned hole. Accordingly, when the blood is introduced into the second tubular container, its contact with the blood test reagent is prevented, because of the intervention of the water-soluble cover which closes the bottom hole of the second tubular container.
When in measurement, the cover member, if formed of a metal, is magnetically moved from outside by using an external magnet and, if formed of a magnet, by using an external metal or magnet, so that the bottom hole of the second tubular container is caused to expose. As a result, the blood introduced into the second tubular container or the serum or plasma separated from the introduced blood by the following centrifugation is allowed to pass through the bottom hole of the second tubular container and enter the space between the second tubular container and the outer tubular container. This results in bringing the blood, serum or plasma into contact with the blood test reagent for reaction therewith.
In accordance with the invention, as the blood test reagent accommodated in the blood test container according to the invention is partly exposed. The remaining portion of the test reagent is covered with a coating layer so that its contact with the blood is prevented. This configuration serves to suppress undesired swelling of the blood test reagent and thus eases ascertainment of test results.
In accordance with the invention the blood test container has a sliding switch is mounted, for vertical movement, to a side wall of the tubular container in such a manner as to grip the side wall. The blood test reagent is secured to a sliding switch portion located within the tubular container.
Accordingly, after introduction of the blood into the tubular container, the blood test reagent can be brought into contact with the introduced blood for reaction therewith by operating the sliding switch to move the blood test reagent downwardly.
That is, the contact of the blood with the blood test reagent can be initially prevented by selecting a volume of the blood introduced such that its level is located in elevation below a bottom edge of the blood test reagent. Also, when in measurement, the blood test reagent can be immersed in the blood, serum or plasma for contact therewith simply by operating the sliding switch.
In accordance with the invention the blood test container further includes a tube having a smaller diameter than the tubular container and accommodated in the tubular container. The tube has a bottom end located at a position below the lowest position that the sliding switch can assume. When in measurement, the blood is introduced into the tube. Since the bottom end of the tube is located at a position below the lowest position that the sliding switch can assume, the blood introduced is hardly allowed to adhere to the sliding switch mounted on the side wall of the tubular container. Accordingly, in an exemplary case where the tubular container is provided with an elongated cutout or the like for vertical movement of the sliding switch therealong, the blood is prevented from leaking through the cutout to outside.
Preferably, the aforementioned tube is located axially centrally of the tubular container. While not intended to limit the invention, the following techniques (1)-(3) can be utilized to locate the tube at such a position. (1) A lid member is provided closing a top opening of the tubular container and the top end of the tube is secured onto a bottom face of the lid member as by an adhesive. (2) A stopper is fitted into the top opening of the tubular container and the top end of the tube is secured onto a bottom face of the stopper. The securement can be achieved with the aid of an adhesive or by threading the top end of the tube into the stopper. (3) Engaging means is provided for engageably suspending the the top end of the tube from the open end of the tubular container.
A blood test container according to the invention further includes a closed-bottom second tubular container arranged to accommodate the tubular container mounting the sliding switch, as well as a stopper provided to simultaneously close respective top openings of those two tubular containers. Also, those two tubular containers are both reduced in interior pressure. The second tubular container may be detached either after the blood is collected according to a vacuum blood-collecting technique or, when needed, after the serum or plasma is centrifugally separated from the blood. The measurement can be accomplished in the same manner as used for the blood test container. A series of procedures from blood collection till measurement of various blood components can thus be readily practiced while eliminating the chance for the tester to contact the blood.
In accordance with the invention the blood test container according to the invention is reduced in interior pressure. This allows the blood to be readily introduced into the blood test container according to a vacuum blood-collecting technique.
In accordance with the blood test method, the blood test can be readily accomplished by introducing the blood into the blood test container and allowing the blood or its component to contact the aforementioned blood test reagent.
In accordance with the blood test method, the blood test can be readily accomplished by introducing the blood into the blood test container, centrifuging the blood and then allowing a component of the blood to contact the blood test reagent. The blood component, as used herein, may be serum or plasma, for example. The blood test container, includes a closed-bottom tubular container and a test reagent for immunochromatography fixed within said tubular container. In accordance with the blood test container, a portion of said test reagent for immunochromatography is exposed and the remaining portion thereof is covered with a protective layer so that the contact of the test reagent for immunochromatography with blood or the like is prevented at the remaining portion.